Focal treatment of localized prostate cancer aims to destroy the cancerous foci without damaging surrounding tissues to avoid the side effects of radical treatments. This is why focal treatment is positioned as an alternative to radical surgery as well as an alternative to active surveillance. This study is a feasibility study. It aims at treating the index tumor (the most aggressive one) which determines the vital prognosis of patient, while preserving the maximum surrounding prostatic tissue to preserve quality of life. The expected result is the total destruction of aggressive tumor areas by focal or multifocal treatment strategy using the Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by the negative biopsy rate between 6 and 12 months post-treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Focal High Intensity Focused Ultrasound (HIFU) treatment for localized prostate cancer (maximum two foci). HIFU treatment is using high energy ultrasound focused at the focal point to achieve precise tissue destruction. This mini-invasive therapy is using an endo-rectal approach to deliver the treatment, using a probe composed of a combined imaging and treatment transducer. The treatment is monitored by real-time ultrasound. The treatment planning is performed by the urologist, contouring the area to be treated (MRI target + security margins around the tumor) and the treatment phase is automatically performed by the robotic device.
Hospices Civils de Lyon - Hôpital Edouard Herriot
Lyon, France
Negative Biopsy Rate in the treated area
Time frame: Between 6 to 12 months after treatment
Evaluation of positive biopsy rate in the untreated areas
Time frame: Between 6 to 12 months after treatment
Rate of side effects
Time frame: At 12 and 24 months after treatment
Prostate Specific Antigen (PSA) level evolution after treatment
Time frame: 24 months
Prostate Symptoms
International Prostate Symptoms Score (IPSS) questionnaire
Time frame: 1 and 2 years(s)
Continence
International Continence Society (ICS) questionnaire
Time frame: 1 and 2 years(s)
Erectile Function
International Index Erectile Function (IIEF-5) questionnaire
Time frame: 1 and 2 years(s)
Quality of life
European Organization for Research and Treatment Quality of Life Questionnaire C30 (EORTC QLQ-C30) questionnaire
Time frame: 1 and 2 years(s)
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